Medtronic SynchroMed Pump Problems Linked to Unapproved Drugs

Medtronic is warning that its SynchroMed II and SynchroMed EL pumps are failing at a high rate, indicating that the problems are occurring because of the use of unapproved drugs in the infusion pumps. 

In an Urgent Medical Device Safety Notification sent to doctors last month, Medtronic warned that the use of drugs not approved for use with the SynchroMed infusion pumps could cause motors to stall.

The FDA has declared the action to be a Medtronic SynchroMed Infusion Pump recall and has given the action a Class I medical device recall designation, even though the pumps are still on the market. Class I recalls are the most serious classification of recall and means the FDA believes the devices could cause severe injury or death due to the problem.

According to Medtronic, the normal failure rate of its SynchroMed infusion pumps is 2.4% after 6.5 years of use. When unapproved drugs are used in the device, the failure rate jumps to 7%. However, Medtronic indicates that there have been no deaths linked to the Synchromed pump problems.

In July, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.

Drugs approved for use in the SynchroMed infusion pumps include Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The FDA and Medtronic are warning customers not to use any compounded drugs, unapproved concentrations or unapproved formulations with these pumps.

The Medtronic SynchroMed Infusion Pump line has been plagued by problems over the last couple of years. In February 2011, the FDA declared a Class I recall for Synchromed pumps following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September of last year, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. It too received a Class I recall designation.